FDAFDA · Food and drugs·Recall number D-1058-2020
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Published March 25, 2020 · Recall initiated: March 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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